Rigenerand Develops 3D Bioreactor for Extracellular Vesicle Exosomes Production

July 31, 2020

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

Challenges in Bulk Drug Substance Management

July 31, 2020

Biopharma Insights—Thought Leadership from Marketers | Paid Program

Final liquid drug substance production and fill–finish activities rarely occur at the same site. Nearly all pharmaceutical and biotechnology companies outsource a portion of their fill–finish needs to contract manufacturing organizations (CMOs) to help them address unexpected demand, satisfy second source policies, or better match scale with need.

Vico Therapeutics Raises $31 Million in Series A Financing Round

July 30, 2020

Vico Therapeutics has raised $31 million (€27 million) in a Series A financing round, which the company will use to further advance its Antisense OligoNucleotides lead platform.

Intravacc and Celonic Partner for COVID-19 Vaccine Development

July 30, 2020

The companies will combine Intravacc’s OMV delivery platform with S-proteins with Celonic’s CHOvolution mammalian cell expression system to produce B and T-cell responses against SARS-CoV-2.

LGM Pharma Acquires Nexgen

July 30, 2020

The acquisition gives LGM access to Nexgen’s manufacturing and warehouse distribution facilities and a pilot plant.

Avacta, Daewoong Pharmaceutical Expand Collaboration to Include COVID-19 Therapy

July 30, 2020

Avacta Group has expanded its partnership with Daewoong Pharmaceutical to include Affimer molecules that target viruses, such as coronavirus.

Avid and Argonaut Enter into Manufacturing Solutions Co-Marketing Agreement

July 30, 2020

The companies will utilize Avid’s upstream and downstream process development and drug substance manufacturing services in conjunction with Argonaut’s parenteral drug product fill-finish services for the delivery of CGMP parenteral drug products for use in clinical studies.

Novartis and Sangamo Announce Gene Therapy Collaboration for up to $795 Million

July 30, 2020

Sangamo will receive a $75 million upfront license fee payment and will be eligible to earn up to $720 million in other development and commercial milestone payments, including up to $420 million in development milestones and up to $300 million in commercial milestones.

Cerevel Therapeutics Enters into $445 Million Deal with Arya Sciences

July 30, 2020

The transaction is expected to be completed during the fourth quarter of 2020.

EMA Starts Review of Dexamethasone as COVID-19 Treatment

July 30, 2020

EMA has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.

Analytical Tools for PAT Implementation for the Characterization of Biosimilars

July 30, 2020

Sponsored Content

This event will aim to present an overview of how analytical technologies can be adapted for implementation of Process Analytical Technology (PAT) in bioprocessing and how this can result in effective process control, thereby delivering consistent process performance and product quality. Live: Europe Broadcast: Thursday, Jul. 30, 2020 at 9am EDT| 2pm BST| 3pm CEST US Broadcast: Thursday, Jul. 30, 2020 at 2pm EDT| 1pm CDT| 11am PDT On demand available after final airing until Jul. 30, 2021

Sterling Pharma Signs Agreement to Support COVID-19 Treatment Development

July 29, 2020

Sterling Pharma Solutions has signed a deal with Moleculin Biotech to support the development of WP1122, a potential COVID-19 treatment.

EC Grants Marketing Authorization for Remsima

July 29, 2020

Celltrion Healthcare has announced that the EC has granted marketing authorization for its subcutaneous formulation of Remsima (infliximab, CT-P13).

DuPont and Rutgers University Enter Research Collaboration

July 29, 2020

DuPont Nutrition and Biosciences has entered into a research collaboration in microbiome science with the Center for Advanced Biotechnology and Medicine at Rutgers University.

CPhI Japan Moves to Spring 2021

July 29, 2020

Following a review, CPhI Japan has been postponed until April 14–16, 2021 to ensure positive business conditions and greater attendance.

One-Step Cell Clarification and Sterile Filtration

July 28, 2020

The paper reviews a new 24-well filter plate that clarifies and sterile filters high-density cells in one step in minutes. Its depth filter efficiently clarifies cells while a dual-layer membrane provides high-performance sterile filtration

FDA Grants Accelerated Approval to First CAR-T Treatment for Mantle Cell Lymphoma

July 27, 2020

The approval comes after positive results were met in a single-arm, open-label study that resulted in FDA Breakthrough Therapy Designation for the one-time therapy.

Stakeholders Seek Increased User Fee Support for Biologics

July 24, 2020

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

UK Government Provides Cash Boost for COVID-19 Vaccine Manufacture

July 23, 2020

The UK government is committing a further £100 million (US $127 million) to ensure that there is capability to manufacture a successful COVID-19 vaccine at scale in the UK.

EMA Sets Up Infrastructure to Support Real-World Monitoring of COVID-19 Vaccines

July 23, 2020

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.